|
Device | TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) |
Generic Name | Coronary drug-eluting stent |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P060008 |
Supplement Number | S009 |
Date Received | 12/15/2008 |
Decision Date | 01/14/2009 |
Withdrawal Date
|
12/06/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REMOVAL OF THE REJECT CRITERIA FOR THE PROXIMAL WELD CREASE ON ALL PRODUCT SIZES. |